Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change - Full Text View

Sponsored by:	Royal Brisbane and Women's Hospital
Information provided by:	Royal Brisbane and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00103636

Purpose

The purpose of this study is to investigate the effects of extending the dwell time of peripheral intravenous cannulas on clinical outcomes and cost.

Condition	Intervention	Phase
Phlebitis	Procedure: Extending peripheral intravenous (IV) cannula dwell times	Phase II Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Peripheral Venous Catheter Trial: 3 Day Versus No Routine Change

Further study details as provided by Royal Brisbane and Women's Hospital:

Primary Outcome Measures:

Phlebitis during the course of the infusion and up to 48 hours after peripheral venous catheter removal

Secondary Outcome Measures:

Infiltration permeation of IV fluid into the interstitial compartment
Local infection at the site of the catheter
Catheter-related blood stream infection
Catheter colonization
Cost

Estimated Enrollment:	200
Study Start Date:	March 2004
Estimated Study Completion Date:	December 2004

Detailed Description:

Among hospitalized patients, intravenous therapy is the most common invasive procedure. It is associated with a phlebitis rate of between 1.1% and 63% and a central venous catheter related bacteremia rate of approximately 3.0%. Catheter related blood-stream infections have an attributable mortality rate of 12% to 25%. Factors thought to be associated with these complications include insertion techniques, catheter securement, type of catheter used, type of infusate and additives, post-insertion catheter care and length of time the catheter remains in place.

Current Centers of Disease Control Guidelines provide direction for intravenous therapy management including a recommendation that peripheral intravenous catheters should be re-sited every 72-96 hours. Data underpinning the recommendation was collected in 1992, over a decade ago. Since that time, there have been improvements in catheter design and composition, and prospective surveillance studies have demonstrated the safety of longer dwell times. To date, these observations have not been validated in adults, using randomized controlled trial methodology.

Re-siting intravenous cannulas causes discomfort to patients and has a high recurrent cost. The primary aim of the present study is to compare the rates of peripheral catheter-related blood stream infection, catheter-related local infection, phlebitis and obstruction between two groups of patients - those having routine catheter changes every 72 hours and those having catheter changes only when clinically indicated.

Specific hypotheses:

That changing intravenous peripheral catheters when indicated by clinical signs compared to changing intravenous catheters every 3 days reduces the incidence of intravenous catheter related morbidity.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients are eligible to join the Peripheral Venous Catheter Trial if:

They are inpatients at the Royal Brisbane and Royal Women's Hospital who are at least 18 years of age

AND

They are scheduled or expected to have a peripheral venous catheter indwelling for at least 4 days.

AND

They have had their catheter inserted by a nurse from the IV Therapy Team

Exclusion Criteria:

Patients with an existing bloodstream infection
Those receiving immunosuppressive treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103636

Locations

Australia, Queensland
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029

Sponsors and Collaborators

Royal Brisbane and Women's Hospital

More Information

Study ID Numbers:	RBWH 2003/131
Study First Received:	February 11, 2005
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00103636
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Royal Brisbane and Women's Hospital:

Phlebitis/etiology
Infusions
Intravenous/adverse effects
Randomised controlled trial

Phlebitis/prevention
Adult
Time factors

Study placed in the following topic categories:

Vasculitis
Peripheral Vascular Diseases
Phlebitis
Vascular Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009